MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for KRONNER MANIPUJECTOR - UTERINE MANIPULATOR-INJECTOR 6003 manufactured by Coopersurgical, Inc..
[178214511]
Portion of catheter broke off and retained in uterus. Not noted catheter broke during surgery. Pt reported catheter fell out of vagina at home.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092809 |
| MDR Report Key | 9677012 |
| Date Received | 2020-02-05 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-08-06 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KRONNER MANIPUJECTOR - UTERINE MANIPULATOR-INJECTOR |
| Generic Name | INSUFFLATOR, CARBON-DIOXIDE UTEROTUBAL (AND ACCESSORIES) |
| Product Code | HES |
| Date Received | 2020-02-05 |
| Model Number | 6003 |
| Catalog Number | 6003 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DR. TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-05 |